Opella · 2 weeks ago
Regulatory Affairs Lead - Pain and Icy Hot
Morristown, NJ
Full-time
Onsite
Senior Level
$125K/yr - $143K/yr
5+ years expOpella is a self-care challenger with a significant portfolio in the OTC and VMS market. The Regulatory Affairs Lead for Pain and Icy Hot will oversee regulatory affairs for the Pain portfolio in the US, focusing on regulatory strategies, product labeling, and compliance activities.
Health CarePersonal HealthRetail
Responsibilities
Develop regulatory strategies for innovation and maintenance of business projects by leveraging a strong understanding of the US OTC drug monograph system and NDA/ANDA drug registration pathways
Represent US Regulatory Affairs as a cross-functional member on project teams
Act as the regulatory affairs reviewer/approver for advertising/promotion on assigned product portfolio
Oversight of labeling activities for assigned products, including creation of Drug Facts Labeling for new product launches and assessing/reviewing/approving label changes to marketed products
Support the monitoring of the US regulatory environment to identify and asses impact of any trends/proposed changes that could impact assigned portfolio of products
Support other projects/duties as needed, such as external engagement activities
Qualification
Required
Minimum B.A. or B.S
Minimum 5-8 years of experience in regulatory affairs across multiple regulatory classes (NDA, Monograph, Device, Cosmetic and/or Food/Dietary Supplement), with at least 4 years of direct regulatory affairs experience with over-the-counter drugs
Fluent English required
Preferred
M.A or M.S., Pharm D, MD, PhD, or equivalent
Benefits
Employees may be eligible to participate in Company employee benefit programs.
Company
Opella
Opella is a consumer healthcare business segment of Sanofi.
10001+ employees
Funding
Current Stage
Late StageTotal Funding
unknown2024-10-20Acquired
Recent News
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